Comparisons of efficacy and safety between Tenofovir and Entecavir drugs in chronic hepatitis B patients

Comparisons of efficacy and safety between Tenofovir and Entecavir in chronic hepatitis B patients: an open level randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18291875

Enrollment

288

Registered

2019-09-03

Start date

2012-04-01

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Infections and Infestations Hepatitis B

Interventions

This was a randomized, open-label study in NA-naïve HBeAg-positive and HBeAg-negative patients with CHB. Each patient was randomized 1:1 to receive ETV 0.5mg or TDF 300mg once daily f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria included three populations: 1. Chronic hepatitis B patients with hepatitis B virus surface antigen (HBsAg) 1.1 Positive status for more than 6 months 1.2 Elevated alanine transferase (ALT) levels = 5x ULN (200 IU/L) or ALT levels between 2x and 5x ULN combined HBV DNA =20000 IU/ml for HBeAg positive patients 1.2 ALT levels over 2x ULN combined HBV DNA =2000 IU/ml for HBeAg negative patients 2. Acute hepatic decompensated patient (prolong prothrombin time >3 sec and bilirubin>2 mg/dL) with positive for HBsAg 3. Clinical cirrhosis with HBV DNA =2000 IU/ml. The clinical evidence of cirrhosis was defined by one of the following 3.1 Ultrasound diagnosed liver cirrhosis with evidence of splenomegaly or esophageal or cardiac varices 3.2 Liver biopsy diagnosed liver cirrhosis 4. Aged 20 years or older.

Exclusion criteria

Exclusion criteria: 1. Patients who had co-infection with human immunodeficiency virus, hepatitis C virus, hepatitis D virus or hepatitis E virus by serological assays 2. Patients who had a significant intake of alcohol (>20g/day for women; 30 g/day for men)

Design outcomes

Primary

Measure	Time frame
Proportion of patients with undetectable HBV DNA level at week 48, 96 and 144. Serum HBV DNA levels were analyzed using the Cobas AmpliPrep-Cobas TaqMan HBV test (CAP-CTM)(Roche Molecular System, Inc., Branchburg, NJ, USA), with a lower detection limit of 70 copies/ml	—

Secondary

Measure	Time frame
1. Presence of HBsAg, HBeAg was assessed using electrochemiluinesence immunoassay (ECLIA) 3.0 2. Renal function measured by the serum creatinine and estimated glomerular filtration rate (eGFR) 3. Anti-HDV antibodies was assessed using radioimmunoassay (Abbott, North Chicago, IL, USA)	—

Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026